U.S. patent number 5,059,202 [Application Number 07/541,505] was granted by the patent office on 1991-10-22 for tendon approximator.
This patent grant is currently assigned to The Montefiore Hospital Association of Western Pennsylvania. Invention is credited to Marc D. Liang, Krishna Narayanan, Eugene D. Ross.
United States Patent |
5,059,202 |
Liang , et al. |
October 22, 1991 |
Tendon approximator
Abstract
A tendon approximator employs two connected, normally closed
clamps, which are each formed from two extruded elements. The two
extruded elements are connected together in their mid-region by
means of non-circular cam on a base element and a corresponding
non-circular cam surface on a clamping element. In the normally
closed position of the individual clamps, the cam and cam surface
urge the device into a jaw-closed position with the handles being
spaced apart. In a preferred embodiment two of the clamps are
connected by means of rods extending through corresponding handle
portions of the two clamps.
Inventors: |
Liang; Marc D. (Pittsburgh,
PA), Narayanan; Krishna (Pittsburgh, PA), Ross; Eugene
D. (Southampton, PA) |
Assignee: |
The Montefiore Hospital Association
of Western Pennsylvania (Pittsburgh, PA)
|
Family
ID: |
26949904 |
Appl.
No.: |
07/541,505 |
Filed: |
June 21, 1990 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
Issue Date |
|
|
263518 |
Oct 27, 1989 |
4957500 |
|
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Current U.S.
Class: |
606/150;
606/157 |
Current CPC
Class: |
A61B
17/11 (20130101); A61B 17/1227 (20130101); A61B
17/02 (20130101) |
Current International
Class: |
A61B
17/11 (20060101); A61B 17/12 (20060101); A61B
17/122 (20060101); A61B 17/02 (20060101); A61B
17/03 (20060101); A61B 017/00 () |
Field of
Search: |
;606/150,157,158,221 |
References Cited
[Referenced By]
U.S. Patent Documents
Primary Examiner: Pellegrino; Stephen C.
Assistant Examiner: Jackson; Gary
Attorney, Agent or Firm: Keck; Harry B.
Parent Case Text
CROSS REFERENCES TO RELATED APPLICATIONS
This application is a division of our earlier filed U.S. patent
application Ser. No. 263,518, filed Oct. 27, 1988, now U.S. Pat.
No. 4,957,500.
Claims
We claim:
1. A tendon approximator including two normally closed clamps, each
clamp comprising two connected elements including:
a base element having a base jaw member, a base handle member and a
central, non-circular arcuate cam member; a clamping element having
a clamping jaw member, a clamping handle member and a non-circular
arcuate cam-engaging member; said base element being secured to
said clamping element by engagement of at least a portion of said
cam-engaging member with said cam member; said base jaw member and
said clamping jaw member having confronting surfaces which are in
proximity when said cam-engaging member conforms to the surface of
said cam member;
each said clamp having two transverse bores; a pair of rods fitting
in corresponding ones of said bores to support the said two clamps
in generally parallel relation; at least one of said clamps being
slideable along the said rods with respect to the other of said
clamps.
2. A tendon approximator as defined in claim 1 wherein the said jaw
members of one clamp have corresponding transverse channels to
receive a tendon.
3. The tendon approximator of claim 2 wherein a sharp spike is
positioned in one of the said channels to penetrate and retain a
tendon within the said one of said channels.
Description
BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention concerns a normally closed clamp and more
particularly a normally closed disposable surgical clamp
particularly adapted to pinch a blood vessel (artery or vein) and
to prevent flow of blood through the blood vessel during surgical
procedures. The clamp may be effectively used as a separator as its
jaws open from the normally closed position. Two of the clamps may
be joined in a useful tendon approximator for use in tendon
ligating procedures.
2. Description of the Prior Art
There are numerous available normally closed clamps which are
employed in surgical procedures. Many of the clamps are made of
stainless steel or other sterilizable materials which, because of
their expense, must be recovered, autoclaved or otherwise
sterilized, and reused. Many of the surgical clamps generate
excessive closing pressures in their normally closed position and
as a result may cause damage to the delicate walls of pinched blood
vessels. Some of the available surgical clamps require special
tools for opening the jaws of the clamp to receive a blood vessel.
Some clamps require a special tool to re-open and remove the clamps
when the surgical procedure is completed.
There is a need for a lightweight, inexpensive, sterile clamp which
can be employed as a surgical clamp, easily opened when desired,
providing adequate but not excess closing jaw pressure, easily
removed without the need of additional tools and sufficiently
inexpensive to justify single use without requiring recovery and
re-sterilization.
STATEMENT OF THE PRESENT INVENTION
According to the present invention, a two-piece clamp is provided.
Preferably each part is extruded linearly or molded from
lightweight, flexible, plastic substances. The linear extrusions
are sliced transversely to produce a clamp base member and a clamp
clamping member which are slide-fitted together to form a normally
closed clamp having normally closed jaws at one end and normally
spaced-apart handle members at the other end. In the central region
of the normally closed clamp, a cam member is provided on the base
member and a cam-engaging surface is provided on the clamping
member. The cam member and the cam-engaging surface are engaged at
least in part. The surface of the cam member is a non-circular,
arcuate surface. The cam-engaging surface applies a torque urging
the jaw members into proximity and provides a greater torque when
the jaw members are spaced-apart as a result of drawing together
the handle members.
The clamp can be used by an operating surgeon or his operatory
assistants. The normally closed clamp is opened by squeezing the
handle members together. The normally closed clamp returns to its
normally closed position when the handle members separate. The two
components are preferably fabricated from inexpensive, lightweight,
plastic substances such as polyethylene, polypropylene,
polyurethane, polyesters, polyamides, polycarbonates and other
substances which are limitedly flexible. The clamp base member does
not require the limited flexibility and may be fabricated from
other materials such as rigid plastics, metals, e.g., extruded
aluminum alloy.
The normally closed clamp can also be employed as a separator
device or a spreading device. The jaw members of the normally
closed device can be placed between two tissues and the handle
members can be brought together whereby the jaw members spread
apart to separate the tissues. In this use, the jaw members are
preferably tapered and provided with blunt tips to avoid tissue
damage. The advantage of the present normally closed spreading
device as a tissue separator is that the operator can spread the
jaw members conveniently by squeezing the handle members. Moreover
the extent of movement of the jaw members is predictable; excessive
spreading cannot occur which might result in damage to the
separated tissues. This should be contrasted with the present
tissue spreaders which function in the manner of scissors--the
surgeon spreads apart the handle members causing a corresponding
spreading of the spreader jaw members. Such spreading devices can
be opened excessively causing tissue damage.
The normally closed device also may be employed as a membrane
separator, particularly in delicate surgical procedures such as the
Janneta procedure in which the surgeon separates a nerve from a
blood vessel. The Janneta procedure employs a surgical cutting to
separate a blood vessel from an engaged nerve. Because of the size
of the blood vessels and nerves, the surgery is delicate and has
many pitfalls. The present device permits gentle separation of a
nerve from an adjoining blood vessel. The relative movement of the
jaws is undirectional--that is, one jaw (the base element jaw)
remains stationary while the other jaw moves laterally and can
slide between the contacting nerve and blood vessel. In this manner
the nerve is separated from the blood vessel without requiring
surgery. For this separating use, the device should have tapering,
blunt-tipped jaw members.
A still further use of the present clamp members is in tendon
approximation. Tendon approximators are employed to retain abutting
tendon ends in confrontation to permit surgical ligation of the
tendon. The present clamp members may be provided with one or more
bores extending transversely through one or both of the elements. A
rigid wire or rod, preferably stainless steel, is press-fitted into
the bore of each of two clamps. Each clamp retains one end of a
tendon. The two clamps may be advanced toward each other by sliding
along the one or more wires or rods until the tendon ends are in
confrontation. The clamps will retain that configuration until the
tendon ligation is completed.
A still further alternative to the present invention is to provide
an extruded arcuate finger on one or the other of the clamp members
such that the arcuate finger, extending from one handle member, is
engaged with the inner surface of the other handle member. When the
handle members are drawn together, the arcuate finger is further
distorted and applies an increasing torque tending to return the
clamp to their normally closed position. When the handle members
are released, the arcuate finger applies a torque tending to
restore the normally closed condition. The arcuate finger may be
employed in addition to the non-circular cam surfaces previously
described to maintain the normally closed configuration.
Alternatively the cam surfaces may be circular and all of the
restoring torque may be provide from the arcuate finger.
A further embodiment of the invention is adapted for use as a towel
clamp. At the present time, surgical steel towel clamps are
employed to connect toweling which drapes those regions of a
surgical patient's anatomy which are not exposed during the
particular surgical procedure. Multiple clamps are used to secure
the disposable fabric. The existing towel clamps are normally
surgical steel instruments which are recovered, autoclaved and
reused. In this embodiment of the invention, the jaw members have
concave confronting surfaces and terminate in a tip which
preferably sharpened or pointed. In the normally closed position,
the jaw members are urged into tip-to-tip engagement and the
concave jaw surfaces provide an opening for receiving fabric edges.
In this embodiment, the normally closed clamps can be discarded
along with the towels.
In a still further embodiment, a normally closed clamp is provided
with jaw liners formed from soft pliable material such as plastic,
rubber or preferably foamed polymeric substances. The inserts may
be secured to a confronting jaw surface by means of adhesives or
other fastening techniques. By employing dual durometer extrusion
procedures, the soft pliable jaw liner can be extruded directly
into the clamp element.
DESCRIPTION OF THE DRAWINGS
FIG. 1 is a side elevation of the two piece, normally closed clamp
in its normally closed position.
FIG. 2 is a side elevation of the normally closed clamp in its open
position.
FIG. 3 is a perspective illustration of the clamp of FIGS. 1 and 2
having a vessel secured between the jaws.
FIG. 4 is a side elevation of the normally closed clamp showing a
vessel pinched between the jaws.
FIGS. 5 and 6 are fragmentary illustrations of extrusion blanks for
producing the normally closed clamp.
FIG. 7 is a fragmentary illustration of a base jaw member showing a
transverse channel.
FIG. 8 is a side elevation of confronting jaw members with
confronting channels.
FIG. 9 is a side elevation of confronting jaw members having
corresponding grooves and beads.
FIG. 10 is a side elevation of confronting jaw members having
serrations on the confronting jaw faces.
FIGS. 11 and 12 are side elevations of an alternative construction
of the present normally closed clamp in the normally closed
position (FIG. 11) and in the open position (FIG. 12).
FIG. 13 is a side elevation of a normally closed clamp having
tapered, blunt-tipped jaw members for use as a tissue spreader.
FIG. 14 is a sketch showing the use of the normally closed spreader
device for separating a vein from an engaging blood vessel.
FIG. 15 is a side elevation of an alternative embodiment of the
normally closed clamp in the normally closed position.
FIG. 16 is a side elevation of the embodiment of FIG. 15 in the
open position.
FIG. 17 is a side elevation of a further embodiment of the normally
closed clamp in its normally closed position.
FIG. 18 is a side elevation of the embodiment of FIG. 17 in its
open position.
FIG. 19 is a side elevation of the normally closed clamp
illustrating bores in the base element.
FIG. 20 is a plan view of two normally closed clamps of the type
shown in FIG. 19 connected together to function as a tendon
approximator.
FIG. 21 is a fragmentary side elevation of modified jaw elements of
FIG. 8 engaged in their normally closed position with a secured
tendon.
FIGS. 22 and 23 are side elevation views of a further alternative
construction of the present normally closed clamp in the normally
closed position (FIG. 22) and in an open position (FIG. 23).
FIGS. 24 and 25 are side elevation view of a still further
embodiment of the present normally closed clamp in the normally
closed position (FIG. 24) and in an open position (FIG. 25).
DESCRIPTION OF THE PREFERRED EMBODIMENTS
FIG. 1 is a side elevation of the present, normally closed clamp 10
having a base member 11 and a clamping member 12. The base member
11 includes a jaw member 13, a handle member 14 and a central,
non-circular, cam element 15. The clamping member 12 includes a jaw
member 16, a handle member 17, a central body member 18 including a
cam-engaging surface 19 which is engaged at least in part with the
surface of the central, non-circular, cam element 15.
It will be observed in FIG. 1 that the normally closed clamp 10 has
its jaw members 13, 16 in a normally closed relation and its handle
members 14, 17 in a normally spaced-apart relation. The
cam-engaging surface 19 corresponds to the surface of the cam
element 15 and the plastic material forming the clamping member 12
has a minimum flexure urging the jaw members 13, 16 into
proximity.
In FIG. 2, the handle members 14, 17 are drawn together and the jaw
members 13, 16 are spaced-apart. Confronting surfaces 21, 22 are
presented angularly to one another. It will be further observed
from FIG. 2 that the cam-engaging surface 19 has been distorted
from its normal shape and the surface 19a has advanced upwardly
along the surface 20 of the cam element 15, causing a change in
shape of the cam-engaging surface 19 which creates increased
flexural stress tending to urge the cam-engaging surface 19 back
into its normal position relative to the cam element 15. When the
handle members 14, 17 are released, the flexural stress in the
cam-engaging surface 19 causes the clamp 10 to return to its
normally closed position and, as shown in FIG. 3 and FIG. 4, to
pinch a vessel 23 which is positioned between the jaw members 13,
16.
As shown in FIG. 4, beads 24 may be provided in the outer surfaces
of the handle members 14, 17 to facilitate gripping the clamp
handle member 14, 17.
The base member 11 may be fabricated from non-flexible materials
such as aluminum alloy, stainless steel or rigid plastics. The
clamping member 12 is formed from a limitedly flexible plastic such
as polyethylene, polypropylene, polyurethane, polyesters,
polyamides, polycarbonates and other materials which have
sufficient rigidity to retain their shape when the clamp is
opened--that is, the jaw member 16 and handle member 17 move
together, yet the cam-engaging surface 19 distorts over the outer
surface 20 of the cam member 15 as the clamp is opened and
closed.
Preferably the clamping member 12 and base member 11 are formed
from linear extrusions of the selected thermoplastic material as
shown in FIGS. 5 and 6. FIG. 5 illustrates the extrusion 11' for
the base member 11. FIG. 6 illustrates the extrusion 12' for the
clamping member 12. Each of the extrusions 11', 12' is sliced into
transverse sections having a thickness of about 1 to 15
millimeters.
Additional features of the clamps may include a transverse channel
25 in the base jaw member 13 as shown in FIG. 7. The channel 25
will secure the location of a vessel between the clamp jaws.
As shown in FIG. 8, a channel 26 may be provided in each of the jaw
members 13, 16 to secure the location of a retained vessel.
In order to provide improved gripping between the jaw members, a
plurality of grooves 27 and a plurality of corresponding beads 28
may be extruded in the clamping jaw member 16 and the base jaw
member 13 respectively as shown in FIG. 9.
FIG. 10 illustrates serrations which are extruded in the
confronting surfaces 21, 22 of the clamping jaw member 16 and base
jaw member 13 respectively to improve gripping action of the
clamp.
An alternative embodiment of the present invention is illustrated
in FIGS. 11, 12 wherein the clamp 40 is shown in a normally closed
position in FIG. 11 and in an open position in FIG. 12. The clamp
40 has a base member 41 and a clamping member 42. The base member
41 includes a base jaw member 43, a base handle member 44 and a
base cam member 45. The clamping member 42 has a clamping jaw
member 46, a clamping handle member 47 and a central body member 48
which includes a cam surface 49. In the normally closed position of
FIG. 11, the jaw members 43, 46 are in proximity and the handle
members 44, 47 are spaced-apart. In this condition, the cam member
45 and cam surface 49 exert a minimum torque tending to urge the
jaw members 43, 46 into proximity. When the handle members 44, 47
are brought together as shown in FIG. 12, the cam surface 49 slides
over the cam member 45 and the jaw members 43, 46 are spread-apart.
The torque applied by the cam members 45 and cam surface 49 in the
clamp-open position of FIG. 12 is greater than the torque existing
in the normally closed clamp position of FIG. 11. It will be
observed that the cam member 45 has a non-circular, arcuate shape
and that the cam surface 49 has a corresponding non-circular,
arcuate shape. The flexure of the cam surface 49 causes the clamp
40 to seek the normally closed position shown in FIG. 11.
Use As A Separator
The normally closed clamp of this invention also may be employed as
a separator for separating tissues. The jaw members of the clamp
are tapered and provided with blunt tips as shown in FIG. 13. The
separator device 50 (also a normally closed clamp) has a base
element 51 and a pivotal element 52. The base element 51 has a
tapered jaw member 53, a handle member 54 and a central cam member
55. The pivotal member 52 includes a tapered jaw member 56, a
handle member 57 and a central body portion 58 including a cam
engaging surface 59. Each of the tapered jaw members 53, 56 is
provided with a blunt tip 60, 61 respectively.
The separator device 50 can be employed in surgical procedures
where it is desirable to spread apart body tissues or tendons,
blood vessels, nerves, et cetera. When the handle members 51, 57 of
the separator device 50 are drawn together, the jaw members 53, 56
spread apart to a known width. This is particularly important. The
state-of-the-art spreader devices employ a scissors principle which
requires the operating surgeon to spread the scissors handle
elements in order to spread the scissors jaw elements. Normally
there is no stop mechanism on the existing separator devices.
Excessive spreading may cause tissue damage.
A specialized use of the separator device of FIG. 13 is illustrated
in FIG. 14. A surgical procedure known as the Janneta procedure is
employed to separate a nerve which may be positioned in contact
with a small blood vessel. Customarily in the Janneta procedure, a
nerve is cut away from the engaging blood vessel by means of a
sharp knife. Such cutting requires care and delicacy and presents
opportunities for error. As illustrated in FIG. 14, a blood vessel
62 is shown in contact with a nerve 63. The nerve 63 and blood
vessel 62 are separated at the spaces 64a, 64b. The tapered jaw
members 53', 56' of the spreader device 50' are introduced (as
indicated by the broken line) into the space 64a between the nerve
63 from the blood vessel 62. The operating surgeon squeezes the
handle members 51', 52' until the clamping jaw 56' moves to the
right while the base jaw 53' remains in the space 64a. Thus the
tapered jaw member 56' slides between the nerve 63 and blood vessel
62 urging a separation. The separator device 50' is moved along the
length of the blood vessel 62 until the engagement with the nerve
63 is entirely opened at the space 64b. Thereafter, in the Janneta
procedure, a permanent spacer is positioned between the blood
vessel 62 and the nerve 63 to prevent recurrence of the
contact.
Alternative Construction
As shown in FIGS. 15-18, the resiliency needed to maintain the
clamp in a normally closed position may be provided from an arcuate
finger of resilient plastic material which functions as a spring
element. In FIG. 15, 16, the clamp 10' has an arcuate finger 65
extending from the inner face of the base handle member 14' to the
inner surface of the clamping handle 17'. In the normally closed
condition of FIG. 15, the arcuate finger 65 is distorted and
applies a torque urging the handle members 14', 17' open and
consequently urging the jaw members 15', 13' into proximity. When
the handle members 14', 17' are brought together as shown in FIG.
16, the arcuate finger member 65 is further distorted, thereby
increasing the torque urging the clamp 10' toward its normally
closed position.
Alternatively, as shown in FIGS. 17, 18, an arcuate finger member
66 may be an extension from the clamping handle member 17"" which
engages the inner surface of the base handle member 14", and exerts
a torque urging the jaw members 13", 16" into proximity. When the
handle members 17", 14" are squeezed together as shown in FIG. 18,
the arcuate finger member is further distorted and exerts a greater
torque.
The arcuate finger elements 65, 66 preferably are extruded when the
resilient plastic elements (FIG. 5, FIG. 6) are extruded and are an
integral element of the extrusions 11', 12'.
The arcuate finger elements 65, 66 may be the sole resilient
elements urging the normally closed clamp into its normally closed
condition. Alternatively, the arcuate finger elements 65, 66 may
provide a torque in addition to that which is achieved from the cam
member 15' (15") and the cam engaging surface 19' (19").
Tendon Approximator
The present normally closed clamp, as shown in FIG. 19, may be
provided with one or more bores 67 which extend transversely
through the clamp, preferably, through the base member 11.
As shown in FIG. 20, two or more of the present normally closed
clamps 10A, 10B are positioned parallel to each other and one or
more rigid rods 68, 69 are press-fitted into the bores 67 of the
clamps 10A, 10B to support the clamps 10A, 10B in a parallel
relationship. The resulting assembly functions as a tendon
approximator. As shown in FIG. 20, two ends of a tendon 70A, 70B
are clamped in the clamps 10A, 10B, respectively. The clamps 10A,
10B are then drawn together by sliding one or both of the clamps
10A, 10B along the rods 68, 69. With the abutting ends of the
tendon 70A, 70B in confrontation, an operating surgeon can carry
out a tendon ligation procedure.
The clamps 10A, 10B may be made more effective for use in the
tendon approximator assembly as shown in FIG. 21. The jaw elements
16, 13 of FIG. 8 are reproduced in FIG. 21 with a sharp spike
element 71 extending from an arcuate groove 26 of one jaw element
16 into the arcuate groove 26 of the opposing jaw element 13. The
sharp spike 71 penetrates the tendon 70A to improve the resistance
to tendon pullout from the clamp 10A.
Towel Clamp
A further embodiment of the present normally closed clamp is
particularly useful as a towel clamp. In many surgical procedures,
the anatomy of a surgical patient which is not exposed during the
surgical procedure is covered with drapes or towels, usually made
from non-woven fabric and intended to be discarded after a single
use. In order to secure the towels during the surgical procedure,
the present practice is to use pointed clamps called towel clips
which are customarily fabricated from surgical steel and which are
recovered after each operation for sterilization and reuse. The
clamps are initially expensive and they require costly
sterilization between uses.
A normally closed clamp as illustrated in FIGS. 22, 23 permits
single, throwaway use of an inexpensive normally closed clamp. As
shown in FIGS. 22, 23, the towel clamp embodiment 10A includes a
base member 11A and a clamping member 12A. The base member 11A
includes a handle member 14A, a cam element 15A and a base jaw
member 13A. The clamping member 12A includes a handle 17A, a
clamping jaw member 16A, a central body member 18A and a cam
engaging surface 19A. The base jaw member 13A has a forward tip 31
and a concave surface 33 which confronts the clamping jaw member
16A. The clamping jaw member 16A has a forward tip 32 and a concave
surface 34 confronting the base jaw member 13A. The two concave
surfaces 33, 34 define an opening 35 between the jaw members 13A,
16A.
At least one of the tips 31, 32 is preferably sharpened to a
beveled or pointed edge in order to provide a firm engagement with
a clamped fabric. In the open position of the clamp 10A shown in
FIG. 23, the handle members 14A, 17A are brought together and the
tips 31, 32 separate to provide a throat for receiving within the
opening 35 a substance to be secured by the clamp, for example, the
fabric forming surgical drapes.
Tubing Clamp
A further embodiment of the present normally closed clamp is
particularly useful as a tubing clamp.
A normally closed clamp as illustrated in FIGS. 24, 25 provides
soft resilient liners. The clamp 10B includes a base member 11B and
a clamping member 12B. The base member 11B includes a handle member
14B, a cam element 15B and a base jaw member 13B. A clamping member
12B includes a handle 17B, a clamping jaw member 16B, a central
body member 18B and a cam engaging surface 19B. The base jaw member
13B has a pad 36 which confronts the clamping jaw member 16B. The
clamping jaw member 16B has a pad 37 confronting the base jaw
member 13B. The two pads 36, 37 are formed from a soft, resilient
substance, such as a pliable plastic, preferably a foamed polymeric
composition such as a foamed polyurethane elastomer. The pads 36,
37 may be preformed and secured to the jaw members 13B, 16B by
adhesives or other fastening means. The pads 36, 37 may be extruded
integrally with the clamp members 11B, 12B respectively by well
known dual durometer extrusive procedures.
The lined clamp of FIGS. 24, 25 is of particular value as a tubing
clamp to close fragile tubing without damage to the tubing
walls.
FIG. 25 shows the clamp 10B in its open condition with the two pads
36, 37 spaced-apart to receive an element (not shown) which is to
be clamped.
* * * * *